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Search Results for Validation Manager
Job Title. Location Salary Actions

Senior Validation Engineer

Senior Validation Engineer Our medical device client in Galway requires a Senior Validation Engineer on a permanent basis. The successful candidate will work on planning and execution of all validation activities related to new product introductions. Role/Responsibilities: • Lead all validation activities for the company. Develop project plans for the all validation activities and report to management on the implementation of the plans. • Review all validation processes and documentation at sub-contract manufacturing facilities. • Generate validation d...

Location: Galway,
Senior Validation Engineer 		Galway Not Disclosed
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Validation Manager Career Profile

Validation Manager

The Validation Manager is responsible for the Validation and coordination of operation of machinery and process within the plant. This may be IT systems, various pieces of machinery or Cleaning processes. Salaries start at ca.€32,000 for an entry level position, with an experience Validation Manager being able to command €80,000+. Again, it's an area where many consult on short term contracts, when there is lots of project and construction work in the market.

Key Responsibilities of the Validation Manager

  • To manage all operational validation activities within the client's organisation.
  • To continue to develop and implement a compliant validation strategy for our client.
  • To continue to develop and implement an efficient compliant and cost effective calibration and maintenance programme.
  • To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
  • Be capable of delivering high level reporting to the client's directors.
  • Manage the process for the creation of documentation and requirements to include but not limited to the following:
  • Computer Systems Validation Plans
  • Equipment Validation Plans
  • Cleaning Validation Plans
  • Utility/Facility Validation Plans
  • Components Area Validation Plans
  • Tissue Business Master Validation Plan
  • Despatch Validation Plans
  • Environmental Monitoring Validation Plans
  • Quality Control Validation Plans
  • Scheduling, Planning and review of validation activities.
  • Manage all facets of assigned validation projects while maintaining strong communication with client representative on project status and assistance needed.

Skills & Qualifications:
  • Third level degree in a science/engineering/computer subject as a minimum.
  • At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry.
  • Good understanding and application of GMP and regulatory requirements.
  • Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.
  • Excellent communication / interpersonal skills
  • Previously have managed or supervised a team of experienced engineers in a similar industry.
  • Be a motivator and leader for such a team.
  • Attention to detail.